Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP)

Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as light-blue, speckled, round uncoated tablets, engraved "FIORICET " on one side, and a three-head profile "" on other side. Bottles of 100 (NDC 52544-957-01) and 500 (NDC 52544-957-05).

Storage

Store below 30°C (86°F); dispense in a tight container.

*Trademark of Medical Economics Company, Inc.

Watson Pharma, Inc., A Subsidiary of Watson Pharmaceuticals, Inc.Corona, CA 92880 USA. FDA rev date: 7/18/2002

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